(59 days)
Not Found
No
The summary describes standard medical image processing and visualization tools (3D volume rendering, MPR, 2D analysis) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The VoxelPlus™ is a software application for the display and 3D visualization of medical image data. It does not provide any therapeutic function.
No
The VoxelPlus™ is a software application for the display and 3D visualization of medical image data (CT, MRI). It provides tools for review and analysis of images but does not explicitly state that it makes a diagnosis or aids in making a diagnosis, only processing and displaying existing medical images.
Yes
The device description explicitly states it is a "PC-based software application" and details its functions related to importing, processing, and displaying medical images. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, the VoxelPlus™ software application is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description of VoxelPlus™ clearly state that it processes and visualizes medical image data (CT, MRI) derived from imaging scanners, not biological specimens.
- IVDs provide information for the diagnosis, monitoring, or treatment of diseases or conditions. While VoxelPlus™ is used by trained professionals in a medical setting and aids in the review of medical images, its primary function is the display and visualization of existing image data. It doesn't perform tests on biological samples to provide diagnostic information in the way an IVD does.
- The description focuses on image processing and visualization tools. The features mentioned (3D volume rendering, MPR, 2D analysis tools) are related to manipulating and viewing image data, not analyzing biological samples.
The device description aligns with a medical image processing and visualization software, which falls under a different regulatory category than IVDs. The predicate device listed (PLUG 'N VIEW 3D) also appears to be a medical image processing system, further supporting this conclusion.
N/A
Intended Use / Indications for Use
The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners. MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Product codes
LLZ
Device Description
Mevisys VoxelPlus™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including physicians, nurses, and technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the word "MEVISYS" in bold, black letters. Below the word "MEVISYS" is the word "(주)메비시스" in a smaller font. The letters in "MEVISYS" are thick and blocky, while the letters in "(주)메비시스" are thinner and more delicate.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: July 25, 2002
Submitter's Information: 21 CFR 807.92(a)(1) Mevisys, Co., Ltd. Alumni Venture Hall, Room 5103 KAIST, 400 Gusongdong Yusonggu Daejon 305-701 Korea
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) VoxelPlus™ Trade Name: Common Name: Picture Archiving Communications System Device Classification: 892.2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K992654 |
| Device Name | PLUG 'N VIEW 3D |
| Applicant | VOXAR LIMITED |
| BONNINGTON BOND, 2 ANDERSON PL | |
| EDINBURGH, UK EH6 5 NP | |
| Contact | ROB MACKEAN |
| Product Code | LLZ |
| Date Received | 08/09/1999 |
| Decision Date | 11/05/1999 |
Device Description: 21 CFR 807 92(a)(4)
Mevisys VoxelPlus™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.
1
Image /page/1/Picture/0 description: The image shows the word "MEVISYS" in a bold, sans-serif font. The first part of the word, "MEVI," is in solid black, while the "SYS" portion is outlined in black. Below the word "MEVISYS" is the Korean text "(주) 메비시스".
Indications for Use: 21 CFR 807 92(a)(5)
The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners. MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is a software application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for VoxelPlus™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. VoxelPlus™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines, giving it a modern and abstract appearance. The seal is black and white.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
OCT 11 2002
Mevisys Co., Ltd. % Mr. Carl Alletto 1100 Lakeview Blvd. DENTON TX 76208 Re: K022692
Trade/Device Name: VoxelPlus™ PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: June 27, 2002 Received: August 13, 2002
Dear Mr. Alletto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "MEViSYS" in a stylized font. The letters "MEV" are solid black, while the letters "SYS" are outlined in black with a white fill. The "i" in "MEViSYS" is dotted with a small circle.
(주)메비시스
Page 1 of -1
(Indications for Use Form)
510(k) Number: Ko 22 6 9 2
Device Name:
VoxelPlus™ by MEViSYS Co. Ltd.
Indications for Use:
The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel li. Lennon
510(k) Number